Effects of Nystatin Suspension Oral Application on Oral Microbial Community

Completed · Phase 1

Conditions studied: Dental Caries

In brief

The purpose of this study is to examine the effect of a prescription mouth rinse (Nystatin),an FDA approved drug, on the different types of bacteria in the mouth. Results from this study may help understand the effect that Nystatin oral rinse has on certain types of oral bacteria, which may also cause tooth decay.

Key facts

Study ID

NCT04550546

Run by

University of Rochester

People needed

20

Starts

2021-05-15

Expected to finish

2022-02-28

Last updated by the study team

2022-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing to participate in this study and able to come for follow-up appointments.
• Has positive oral Candida detection and the amount of oral Candida meet the laboratory criteria for diagnosing oral Candidiasis (>= 400 colony forming unit in saliva).
• Has ≥ 10,000 CFU/mL of S. mutans in the saliva (justification: individuals with ≥ 10,000 CFU/mL salivary S. mutans are considered at elevated risk for dental caries).
• Ability to consent, comply with all study procedures and be available for the duration of the study.

You may not qualify if…

• visible signs of candidiasis on the mucosa or tongue at screening (Patients will be referred for treatment immediately)
• Patient with systemic diseases, such as HIV, cancer or diabetes. This will be answered by study participants and further confirmed by using electronic medical record (EPIC) for those participants who have records in the EPIC system. (Justification: patient with systemic diseases is that patients with these conditions are more prone to yeast and bacterial infection)
• History of local (oral) or systemic antibiotics or antifungal medication within the last 3 months. This will be answered by study participants and further confirmed by using electronic medical record (EPIC) for those participants who have records in the EPIC system.
• Women who are currently pregnant or reported that she is currently breast feeding . A pregnancy test (urine test) will be conducted to exclude participants who are pregnant. Rational of excluding pregnant women and women are currently breastfeeding their children: Nystatin oral suspension is classified as FDA pregnancy risk category C. It's also unknown whether nystatin is excreted in human milk.

Where it is running

• Eastman Dental Institute — Rochester, New York, United States

Full record on ClinicalTrials.gov

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